The solicitation response date is hereby extended until 13:00 hours Central Time on August 24, 2012.

QUESTION 1: Our primary concern and question is in reference to two items under the heading performance requirements. In item 1 you mention 21 CRF Parts 11 and 58 compliance and Item 6 requires "validation" of the system. To be truly compliant and fully validated a system of this type must be taken through and have completed GLP validation. We offer GLP validation services but it is our understanding of the FDA requirements for GLP system validation that the end user institution must complete the validation and no manufacture can fully validate such a system for use in GLP studies as it would potentially be a conflict of interest for the manufacturer to do so. Again we can offer GLP validation service and assistance but cannot validate a system. Validation Service therefore based on our understanding of this solicitation is required. If the system must simply be capable of being validated then we believe that the language under "Performance requirements:" items 1 and 6 should be revised to state that the system must be capable of being validated by the FDA. We would therefore expect that GLP system validation be added as a line item on the solicitation if manufacturer assistance for GLP system validation is required. We can quote validation services per day or week but we cannot determine for any institution how much assistance will be required, this is based on your own resources, expertise and internal checks and balances necessary to assure the system is fully GLP compliant.

ANSWER 1: The term validation in Item 6 should be interpreted that the system is installed and fully functional as designed. It should not be interpreted as "GLP validation". The purchased system will be used in GLP studies, and as such, will require the end-user (US Government) to develop procedures in accordance with 21CFR58. The manufacturer should be familiar with 21CFR11 requirements for documentation. The question correctly points out that GLP compliance is the end-user responsibility. The manufacturer can provide an optional quote for developing GLP validation plan.

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QUESTION 2: In the questions and answers that were added on 8/1/2012 three different plethysmograph chambers are mentioned but no quantities for each size are referenced. How many chambers of each size are required?

ANSWER 2: We require a total of 8 nose-only exposure chambers for medium sized rats.

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QUESTION 3: The schedule of items for this solicitation indicates a quantity of 8 systems, is this correct? If so as requested in the previous paragraph we would need to know the number and type of rodent plethysmograph chambers required for each of the 8 systems; or is the quantity of 8 the number of chambers needed and the number of animals to be monitored simultaneously on one system.

ANSWER 3: We require 8 chambers, nose-only exposure for medium sized rats. We want the ability to simultaneously monitor 8 rats in the chambers. The number of monitoring systems (e.g. computer and software) will depend on the vendors system, either one system monitoring all 8 rat chambers simultaneously, or two systems each monitoring 4 rats chambers simultaneously.

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QUESTION 4: What is the total number of animals that will be monitored at the same time during an experiment?

ANSWER 4: The total number of animals to monitor at any given time is 8 rats in nose-only plethysmograph chambers.

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QUESTION 5: Please specify how many rats and/or how many mice will be used during the experiment?

ANSWER 5: The total number of animals to monitor at any given time is 8 rats in nose-only plethysmograph chambers. The total number of rats on a given study is irrelevant to the solicitation.

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QUESTION 6a: According to the changes posted on Aug. 1st. "The government will be using the TSE small and Medium rat restrainers and medium mouse restrainers", it is unfortunately not possible to use such restrainers as NOIES Plethysmograph chambers, unless they are sealed. Therefore, can you please confirm that your current restrainers are sealed and are equipped with pneumotachographs fitted with two openings for a differential pressure transducer?

ANSWER 6a: No, the current system does not have pneumotachographs and pressure transducer. The solicitation requested that the quoted chambers integrate with the TSE exposure system.

QUESTION 6b: If your answer to question above is negative, do you want us to provide the appropriate mice and rats NOIES Plethysmograph chambers, with custom adapters to fit your current inhalation tower manufactured by TSE Systems?

ANSWER 6b: Yes. We desire new chambers as stated in the question.

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QUESTION 7: Is there any chance that the plethysmograph chambers that connect to the TSE NOIES can be removed from this solicitation. Since they are only manufactured by TSE, are financially a small part of the total system price and we add no value reselling their chambers and cannot warranty their equipment or speak to their quality we would prefer to not have to quote these items. We can do so if necessary but our preference would be to not have to add these to the system.

ANSWER 7: To be clear about the instrumentation, we need 8 medium rat plethysmograph chambers that will fit into the receiver for a TSE inhalation system. The plethysmograph chambers are then equipped with pressure/flow transducers to measure breathing, and this is recorded onto a plethysmography system. The key is that we need 8 plethysmograph chambers that connect to the TSE inhalation system, as outlined in the solicitation.

Bid Protests Not Available